Scientific Issues Associated with Designating a Prion as a “Pest” under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and Related E

March 31 - April 1, 2009


Panel Member List FIFRA Scientific Advisory Panel Open Meeting, March 31 - April 1, 2009


Scientific Issues Associated with Designating a Prion as a “Pest” under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and Related Efficacy Test Methods


Environmental Protection Agency Conference Center Lobby Level, One Potomac Yard (South Bldg.), 2777 Crystal Dr., Arlington, VA 22202


FIFRA SAP Website: http://www.epa.gov/scipoly/sap/ Docket Number EPA-HQ-OPP-2008-0859 OPP Docket Telephone: 703-305-5805


FIFRA SAP Session Chair

Steven G. Heeringa, Ph.D. Research Scientist & Director for Statistical Design University of Michigan Institute for Social Research Ann Arbor, MI

Designated Federal Official

Myrta R. Christian, M.S. US Environmental Protection Agency Office of Science Coordination & Policy FIFRA Scientific Advisory Panel EPA East Building, MC 7201M 1200 Pennsylvania Avenue, NW Washington, DC 20460 Tel: 202-564-8450, Fax: 202-564-8382, mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000202/!x-usc:mailto:Christian.myrta@epa.gov

FIFRA Scientific Advisory Panel Members

John R. Bucher, Ph.D., DABT Associate Director Environmental Toxicology Program National Institute of Environmental Health Sciences Research Triangle Park, NC

Janice E. Chambers, Ph.D., DABT, ATS William L. Giles Distinguished Professor Director, Center for Environmental Health Sciences College of Veterinary Medicine Mississippi State University Mississippi State, MS

Kirby C. Donnelly, Ph.D. Professor and Head Department of Environmental and Occupational Health School of Rural Public Health Texas A&M University System Health Science Center College Station, TX

Carey N. Pope, Ph.D. Professor, Head & Sitlington Chair of Toxicology Department of Physiological Sciences Oklahoma State University College of Veterinary Medicine Stillwater, OK

Kenneth M. Portier, Ph.D. Program Director, Statistics American Cancer Society National Home Office Atlanta, GA

Daniel Schlenk, Ph.D. Professor of Aquatic Ecotoxicology & Environmental Toxicology Department of Environmental Sciences University of California, Riverside Riverside, CA

FQPA Science Review Board Members

Jason C. Bartz, Ph.D. Assistant Professor Department of Medical Microbiology & Immunology Creighton University School of Medicine Omaha, Nebraska

Dr. Jason C. Bartz is an Assistant Professor in the Department of Medical Microbiology and Immunology in the School of Medicine at Creighton University where he conducts research on prion diseases. Dr. Bartz received a Ph.D. in veterinary science from the University of Wisconsin where he focused on interspecies transmission and adaptation of prions to new host species. Dr. Bartz has over 15 years of experience in prion disease research and is currently investigating the biology of prion strains. Specifically, Dr. Bartz is interested in the mechanisms of strain-specific routes of neuroinvasion, prion strain targeting in the central nervous system and prion strain interference. Dr. Bartz has been an advisor to panels of the National Institutes of Health and the Department of Defense.

Byron Caughey, Ph.D. Senior Investigator & Chief - TSE/Prion Biochemistry Section Laboratory of Persistent Viral Diseases NIH/NIAID Rocky Mountain Laboratories Hamilton, Montana

Dr. Byron Caughey is a Senior Investigator and Chief of the TSE/prion Biochemistry Section of the Laboratory of Persistent Viral Diseases, Rocky Mountain Laboratories, National Institute for Allergy and Infectious Diseases, National Institutes of Health in Hamilton, Montana. Dr. Caughey got his Ph.D. in Biochemistry from the University of Wisconsin-Madison in 1985. In 1986, after post-doctoral studies in neurochemistry at Duke University, he began TSE/prion research at Rocky Mountain Laboratories. Dr. Caughey has published extensively in the TSE/prion field on biochemical, biophysical, cell biological, diagnostic and therapeutic aspects of TSE/prion diseases. He has served on journal editorial boards and is currently a senior editor for the Journal of Virology. He has been a member of institutional scientific review committees for the Institute for Animal Health (UK) and the NIDDK (NIH), and chaired the TSEs Review Panel for the 2006 USDA Scientific Quality Review. He has been an ad hoc reviewer for numerous granting agencies and is currently a member of the scientific advisory boards of the funding agencies PrioNet Canada and Alberta Prion Research Institute.

Kenneth D. Clinkenbeard, D.V.M., Ph.D. Professor & Coordinator, Veterinary Biomedical Sciences Graduate Program Department of Veterinary Pathobiology College of Veterinary Medicine Oklahoma State University Stillwater, Oklahoma

Dr. Kenneth D. Clinkenbeard is Professor of Veterinary Pathobiology and coordinator of the Veterinary Biomedical Sciences Graduate Program at the College of Veterinary Medicine, Oklahoma State University where he teaches graduate and veterinary students and conducts research in the areas of infectious disease pathogenesis and ecology. Ken earned his PhD degree at The Johns Hopkins University School of Medicine in physiological chemistry in Albert Lehninger’s department studying enzymology and was a NIH postdoctoral fellow under Nobel prize winner Dr. Edwin G. Krebs at the University of California at Davis, where he also earned his DVM degree. Dr. Clinkenbeard has over thirty-five years experience working with infectious diseases including disseminate histoplasmosis in dogs and cats; shipping fever, pinkeye, and E coli O157:H7 in cattle; tularemia and plague in wildlife; and chronic wasting disease in cervids. Recently, he has along with his collaborators from DNA Solutions, Inc. developed an in vitro model for detection and study of chronic wasting disease using an immortalized whitetail deer cell line developed in his laboratory under Phase II Small Business Innovative Research funding from the DoD.

Christina Egan, Ph.D. Director, Biodefense Laboratory Wadsworth Center New York State Department of Health Albany, New York

Dr. Christina Egan is the Director of the Biodefense Laboratory at the Wadsworth Center, New York State Department of Health (NYSDOH). Dr. Egan has been with the NYSDOH since 1999 joining the Wadsworth Center as a New York State Emerging Infectious Disease fellow and then as a research scientist and member of the Bioterrorism Response Team which was responsible for the analysis of environmental and clinical specimens for anthrax in 2001. Dr. Egan has 10 years experience working with biological pathogens and high containment laboratories and has obtained specialized certification as a C.B.S.P (Certified Biosafety Professional) through the National Registry of Microbiologists. She has been involved in the development of new diagnostic assays designed to test clinical specimens and environmental samples for bacterial, toxins, and viral agents and oversees the validation process of these molecular assays. Additionally, she has been involved with the development and presentation of many training courses for laboratorians, first responders, Civil Support Teams, and members of the law enforcement community in New York State. She has participated on a number of different federal, state, and scientific panels and committees such as Association of Analytical Communities Biothreat Methods Committee to create standards for biothreat detection method and the EPA Science Advisory Board. She has numerous publications and book chapters related to the development of diagnostic assays for biothreat assays and other issues related to public health preparedness and is an Assistant Professor in the SUNY School of Public Health, Departments of Biomedical Sciences and Environmental Health Sciences.

Kurt Giles, D. Phil. Assistant Adjunct Professor Department of Neurology Institute for Neurodegenerative Diseases University of California at San Francisco San Francisco, California

Dr. Kurt Giles is an Assistant Adjunct Professor at the University of California San Francisco (UCSF). He is director of the transgenics core and a senior scientist at the Institute for Neurodegenerative Diseases (directed by Nobel laureate Dr Stanley B. Prusiner). Kurt received his Ph.D. in pharmacology from Oxford University, United Kingdom, where he used biochemical tools to determine abnormally functioning proteins in Alzheimer’s disease. This was followed by post-doctoral research at the Weizmann Institute of Science, Israel, where he expanded on these studies focusing on protein structure analysis. Kurt has held faculty positions at the Weizmann Institute and at Oxford University prior to moving to UCSF. He has taught undergraduate and graduate courses, and given workshops in many countries, and serves on the editorial board of the journal Biochemistry and Molecular Biology Education. He is also involved in education outreach with High Schools. Kurt has over 15 years experience in neurodegenerative disease research, and he uses transgenic mouse models to understand the molecular basis of various neurodegenerative diseases. He is an expert in prion diseases, where his research encompasses determining the molecular basis for transmission of prion strains between species, understanding the endogenous function of the prion protein, and devising methods to inactivate prions. He has also pioneered the use of survival analysis techniques to more rigorously quantify prion inactivation. Kurt has published widely on the use of transgenic mouse models to measure prion infectivity, and on the inactivation of prions.

Nancy J. Hanson, Ph.D. Associate Professor Department of Medical Microbiology Director of Molecular Biology Center for Research in Anti-Infectives and Biotechnology Creighton University School of Medicine Omaha, Nebraska

Dr. Nancy D. Hanson is an Associate Professor and Director of Molecular Biology for the Center for Research in Anti-Infectives and Biotechnology in the Department of Medical Microbiology and Immunology at Creighton University. Dr. Hanson received her PhD in Medical Microbiology from the University of Nebraska Medical Center. She joined the faculty of Creighton University in 1995. Dr. Hanson has an active research laboratory and has trained several Master and PhD level students. Her area of expertise involves the study of molecular mechanisms of antibiotic resistance in Gram-negative organisms such as E. coli, K. pneumoniae, Salmonella spp. and Pseudomonas aeruginosa. Her research explores two aspects of antibiotic resistance mechanisms: 1) the regulation of the genes involved in resistance and 2) the development of PCR-based diagnostic tests that can be used by clinical laboratories to detect resistance genes in clinical isolates. Dr. Hanson has served as an ad-hoc grant reviewer for National Institutes of Health study sections, the Wellcome Trust, and the British Society for Antimicrobial Chemotherapy. Dr. Hanson has been the invited speaker for the Australian Society of Microbiology, General Society for Microbiology held in Edinburgh Scotland, the American Society of Microbiology and the Interscience Conference on Antimicrobial Agents and Chemotherapy. She serves as an ad-hoc reviewer for 12 scientific journals. Dr. Hanson has also been involved in the Fulbright mentoring program training recipients of the fellowship from countries such as Nigeria and Egypt. In 2007, Dr. Hanson was awarded researcher of the year by the Nebraska Chapter of the Cystic Fibrosis Foundation for her work on P. aeruginosa infecting patients with cystic fibrosis.

Corinne I. Lasmezas, D.V.M., Ph.D. Professor, Department of Infectology The Scripps Research Institute, Scripps Florida Jupiter, Florida

Dr. Corinne I. Lasmézas is Professor at the Department of Infectology of The Scripps Research Institute, Scripps Florida where she directs a research laboratory focusing on the study of prion diseases. Corinne Lasmézas has a Doctorate of Veterinary Medicine from the University of Toulouse, France, and a Ph.D. in Neurosciences from the University Pierre&Marie Curie in Paris, France. She has over fifteen years of experience in the study of prion diseases. Her research in France has contributed to demonstrate the transmissibility to humans of bovine spongiform encephalopathy by showing the similarity of this prion strain with that of the human variant Creutzfeldt-Jakob Disease. She has established a non-human primate model for the study of the pathogenesis and iatrogenic risk from the bovine prion. She has studied prion pathogenesis in rodent models, including the involvement of the lymphoreticular system, the relationship between infectivity and the misfolded prion protein, prion therapy and the interaction of the prion protein with cell surface proteins. Since 2005 Corinne Lasmézas continues her research in the USA at the newly created Department of Infectology of the Scripps Research Institute located in Jupiter, Florida, where her group focuses on the mechanisms of neurodegeneration in prion diseases, the search for a therapy, and a better understanding of the molecular mechanisms underlying prion replication and the strain phenomenon. She serves as a scientific reviewer for research programs and journals, and is a member of several advisory panels in Europe for issues related to ruminant and human prion diseases including the iatrogenic risk linked to human derived medicinal products.

Laura Manuelidis, M.D. Professor & Head of Neuropathology Department of Surgery Yale University School of Medicine New Haven, Connecticut

Dr. Laura Manuelidis is a Professor and Head of the Section of Neuropathology in the Department of Surgery at Yale, as well as on the interdepartmental faculty of Virology and Neuroscience. She received her MD at Yale and trained in both pathology and neuropathology. Major research contributions have been the discovery and sequencing of alpha satellite DNA and retroviral LINES in the 1970s, with the development of non-isotopic in-situ methods for defining chromosome and nuclear structure at high resolution. She also has done broad diagnostic work as Chief of the Neuropathology service for many years, and has been deeply involved in Creutzfeldt-Jakob disease (CJD) research. The first small animal models of CJD were developed at Yale in the 1970s and these have been fundamental for pathogenesis and infectivity studies. Recent tissue culture models of various CJD and a variety of distinct scrapie agent strains have simplified the study of these agents, including variant CJD (vCJD). The vCJD human isolate is derived from the "mad cow disease" agent (UK BSE). Dr. Manuelidis has been a consultant for the NIH, FDA, NATO, the Wellcome Trust, SEAC and the USDA and continues to participate in editorial boards and activities.

Suzette A. Priola, Ph.D. Senior Investigator & Chief - TSE/Prion Molecular Biology Section Laboratory of Persistent Viral Diseases NIH/NIAID Rocky Mountain Laboratories Hamilton, Montana

Dr. Suzette A. Priola is a Senior Investigator and Chief of the TSE/Prion Molecular Biology Section in the Laboratory of Persistent Viral Diseases at the National Institutes of Health’s Rocky Mountain Laboratories. She obtained her PhD in Microbiology and Immunology from the University of California, Los Angeles and specializes in infectious diseases of the central nervous system. She has over 18 years of research experience in the field of prion diseases during which time her laboratory has identified novel prion disease inhibitors and studied multiple different aspects of prion pathogenesis including how prions infect cells and the molecular basis of prion species barriers and strains. She was a member of the Food and Drug Administration (FDA) Transmissible Spongiform Encephalopathy (TSE) Advisory Committee for five years and Chair for almost three years. She has served as a consultant to both the FDA’s Center for Biologics Evaluation and Research and the World Health Organization (WHO) and was a member of the National Prion Research Program administered by the Department of Defense’s Congressionally Directed Medical Research Programs. She has been an editorial board member at the Journal of Biological Chemistry and is currently on the editorial board of the journal Virology.

Juergen A. Richt, DVM, Ph.D. Regents Distinguished Professor Kansas State University College of Veterinary Medicine Diagnostic Medicine/Pathobiology Manhattan, Kansas

Dr. Jürgen A. Richt, DVM, PhD, is the Regents Distinguished Professor at the College of Veterinary Medicine at Kansas State University in Manhattan, KS. He received his DVM from the University of München, Germany, and his PhD in Virology from the University of Giessen, Germany. Dr. Richt has been working in the area of emerging zoonotic diseases for more than 20 years. In his early research years, Dr. Richt focused on the immunopathogenesis and molecular biology of Borna Disease Virus (BDV). After his move to the United States, Dr. Richt’s work focused on influenza virus infections in animals, especially swine, and on animal transmissible spongiform encephalopathies (TSEs) or prion diseases. Dr. Richt has published more than 90 peer-reviewed manuscripts in his area of expertise. He is one of the Editors for the journal Virus Genes and on the Editorial Board of numerous other journals. His research program is funded by the NIH and the CDC. He was recently appointed to the Scientific Advisory Board of OIE, Paris, France.

Lynne Sehulster, Ph.D. Health Scientist Division of Healthcare Quality Promotion Centers for Disease Control and Prevention Atlanta, Georgia

Dr. Lynne Sehulster is a Health Scientist in the Division of Healthcare Quality Promotion (DHQP) within the National Center for Preparedness, Detection, and Control of Infectious Diseases (NCPDCID) at the Centers for Disease Control and Prevention (CDC). She has been at CDC for 12 years. She received her MS and PhD in Microbiology from Rutgers, the State University of New Jersey, and has her certificate as a Microbiologist with the American Society of Clinical Pathologists (M[ASCP]). Prior to coming to CDC, she completed a postdoctoral assignment in the Department of Virology and Epidemiology at Baylor College of Medicine in Houston doing laboratory research in hepatitis B virus inactivation. She subsequently served as an infectious disease epidemiologist for 15 years at the Texas Department of Health (currently known as the Texas Department of State Health Services). While in Texas she was the state health department’s point of contact for viral hepatitis and influenza epidemiology and surveillance activities. Her current areas of expertise at CDC focus on environmental infection control, transmission of infectious diseases, and microbial inactivation. She advises the agency, health care professionals, and the public on issues concerning indoor environmental cleaning, sterilization and disinfection, prion inactivation and risk assessment, and environmental management of emerging diseases. She also provides perspective to CDC on regulated medical waste and other healthcare facility issues such as laundry and environmental services. She is the coordinator of and contributor to the CDC/HICPAC “Guidelines for Environmental Infection Control in Health-Care Facilities” that was released in 2003.

Claudio Soto, Ph.D. Professor, Department of Neurology University of Texas Medical School at Houston Houston, Texas

Dr. Claudio Soto is the Director of the George and Cynthia Mitchell Center for Neurodegenerative Diseases and Professor on the Departments of Neurology, Neuroscience & Cell Biology and Biochemistry & Molecular Biology at the University of Texas Medical Branch in Galveston. Dr. Soto holds the Green Distinguished University Chair in Neuroscience, the largest endowed professorship in the University of Texas. Currently he is also the Founder, Vice-President and Chief Scientific Officer of AMPRION Inc. He received his PhD in biochemistry and molecular biology from the University of Chile in 1993 and was a postdoctoral fellow at the Catholic University of Chile and at the New York University School of Medicine, where he became an assistant professor of research in 1995. Between 1999-2003, Dr Soto was Senior Scientist, Chairman of the Department of Molecular Neuropathology and Senior Executive Scientific Advisor for Neurobiology at Serono International in Switzerland. For the past 13 years, he and his colleagues have engaged in research into the molecular basis of neurodegenerative diseases associated to the misfolding and brain accumulation of proteins, particularly focusing in Alzheimer’s and prion-related disorders. His work has led to the development of novel strategies for treatment and diagnosis of these diseases. He has published more than 90 peer review scientific publications and contributed to more than 15 books, including one written entirely by Dr. Soto. Many of his studies have been published in the most prestigious scientific journals (including Cell, Nature, Science, Nature medicine, EMBO Journal, etc) and several of them have produced a large impact in the scientific community.




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AGENDAFIFRA SCIENTIFIC ADVISORY PANEL (SAP)OPEN MEETINGMarch 31 - April 1, 2009FIFRA SAP WEB SITE http://www.epa.gov/scipoly/sap/OPP Docket Telephone: (703) 305-5805Docket Number: EPA-HQ- OPP-2008-0859U.S. Environmental Protection AgencyConference Center - Lobby LevelOne Potomac Yard (South Bldg.)2777 S. Crystal Drive, Arlington, VA 22202Scientific Issues Associated with Designating a Prion as a “Pest” under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and Related Efficacy Test MethodsPlease note that all times are approximate(See note at the end of the Agenda)Tuesday, March 31, 20098:30 A.M. Opening of Meeting and Administrative Procedures by Designated Federal Official – Myrta R. Christian, M.S., Designated Federal Official, Office of Science Coordination and Policy, EPA8:35 A.M. Introduction and Identification of Panel Members - Steven G. Heeringa, Ph.D., FIFRA Scientific Advisory Panel Chair8:50 A.M. Welcome and Opening Remarks – Steven Bradbury, Ph.D., Deputy Director, Office of Pesticide Programs, EPA9:00 A.M Background and Overview - Jeff Kempter, Senior Advisor, Antimicrobials Division, Office of Pesticide Programs, EPA9:20 A.M. A Regulatory Approach to C&D for CWD and EPA’s Role in the Process – Dean Goeldner, D.V.M., Chronic Wasting Disease Program Manager, USDA-APHIS-VS-NCAHP-RHP, Riverdale, MD9:40 A.M. FDA Approach to Claims for Reducing TSE Infectivity on Medical Devices - Sheila Murphey, M.D., Chief, Infection Control Devices Branch; Division of Anesthesiology, General Hospital, Infection Control and Dental Devices; Office of Device Evaluation; Center for Devices and Radiologic Health; FDA, Rockville, MD10:15 A.M. Break10:30 A.M. EPA’s “White Paper” – Richard Wiggins, Ph.D., National Health and Environmental Effects Research Laboratory, Office of Research and Development, EPA, Research Triangle Park, NC10:50 A.M. EPA’s Guidance for Efficacy Test Methods for Products Bearing11:15 A.M. Prion Infectivity Assays – Christopher J. Silva, Research Chemist, Foodborne contaminants Research Unit, Western Regional Research Center, Albany, CA11:40 A.M. Transmissible Spongiform Encephalopathies (TSEs/Prion Diseases): Target Criteria for Assessing Agent Clearance – David M. Asher, MD, Chief, Laboratory of Bacterial, Parasitic and Unconventional Agents; Division of Emerging and Transfusion-Transmitted Diseases; Office of Blood Research and Review; Center for Biologics Evaluation and Research; FDA, Rockville, Maryland3:45 P.M. Charge to Panel – Question 11. White Paper Issue: Whether EPA’s draft review paper, “Scientific Information Concerning the Issue of Whether Prions Are a ‘Pest’ under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA),” adequately identifies and summarizes available, relevant scientific studies.Prion-Related Claims – Richard Wiggins, Ph.D., National Health and Environmental Effects Research Laboratory, Office of Research and Development, EPA, Research Triangle Park, NC12:00 P.M. Lunch1:00 P.M. Public Comment3:30 P.M. BreakIn 2005, EPA established a Work Group to develop a Notice of Proposed Rulemaking (NPRM) that defines a prion as a “pest” under FIFRA. To assure that it considers key available scientific studies that are relevant to the issue of whether a prion is a “pest” under FIFRA, the Work Group drafted a review paper. While the paper received intra-Agency review, it was not subjected to peer review outside of EPA. Accordingly, EPA seeks the SAP’s peer review of the attached, draft review paper (USEPA 2008). Some of the key references cited in the review paper have been provided to the SAP.EPA wishes to point out that the NPRM will also focus on legal and policy matters that are not addressed in depth in the “white paper.” EPA is presenting this paper to the SAP solely for review as to its characterization of the scientific issues, and is not asking the SAP to interpret legal/policy issues such as Congress’ intent in drafting FIFRA.•Please comment on the accuracy of the characterization of the nature of prions, and the adequacy of the review of the relevant scientific information to support that characterization, as presented in EPA’s draft paper, “Scientific Information Concerning the Issue of Whether Prions Are a ‘Pest’ under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).”5:00 P.M. AdjournmentOPEN MEETINGAGENDAFIFRA SCIENTIFIC ADVISORY PANEL (SAP)March 31 - April 1, 2009FIFRA SAP WEB SITE http://www.epa.gov/scipoly/sap/ OPP Docket Telephone: (703) 305-5805Docket Number: EPA-HQ- OPP-2008-0859U.S. Environmental Protection AgencyConference Center - Lobby LevelOne Potomac Yard (South Bldg.) 2777 S. Crystal Drive, Arlington, VA 22202Scientific Issues Associated with Designating a Prion as a “Pest” under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and Related Efficacy Test MethodsWednesday, April 1, 20098:30 A.M. Opening of Meeting - Administrative Procedures by Designated Federal Official - Myrta R. Christian, M.S., Designated Federal Official, Office of Science Coordination and Policy, EPA8:35 A.M. Introduction and Identification of Panel Members -Steven G. Heeringa, Ph.D., FIFRA Scientific Advisory Panel Chair8:50 A.M. Follow-up from Previous Day’s Discussion – Jeff Kempter, Senior Advisor, Antimicrobial Division, Office of Pesticide Programs, EPA9:15 A.M. Charge to Panel – Question 22. Efficacy Guidance Test Method Issue: Whether the specific test systems recommended in the draft guidance document are scientifically appropriate to support the registration of pesticide products with prion-related claims.The draft efficacy guidance document (USEPA 2009) recommends a carrier-based, animal infectivity test method, if the intended use of a product is for treating environmental surfaces, and a suspension-based, animal infectivity test method if the intended use of a product is for treating liquids. The draft efficacy guidance document also states that the test methods may either be end-point titration or incubation time interval assays. EPA is interested in knowing the SAP’s opinion on whether these recommended test systems are scientifically sound and appropriate approaches to evaluating the efficacy of pesticide products with prion-related claims. EPA would also like to know whether the SAP recommends that other test methods be considered to evaluate the efficacy of pesticide products used either on•b.3. Efficacy Guidance Performance Criterion Issue: Whether the product performance criterion specified in the draft guidance document to support the registration of pesticide products with prion-related claims is scientifically sound.environmental surfaces or in liquid media.Please comment on the scientific appropriateness of:a.Carrier-based, animal infectivity assays recommended by EPA’s guidance for evaluating the efficacy of pesticide products used on environmental surfaces (e.g., hard, nonporous surfaces).Suspension-based, animal infectivity assays recommended by EPA’s guidance for evaluating the efficacy of pesticide products used in liquid media (e.g., wastewater).Any other known test methods for evaluating the efficacy of pesticide products used on either environmental surfaces or in liquid media.10:30 A.M. Break10:45 A.M. Charge to Panel - Question 3The draft efficacy guidance document recommends a target efficacy criterion of six (6) logs of reduction of infectivity in the treated versus untreated (control) groups. This criterion is widely used in the current scientific literature. EPA would like the SAP’s comment on this proposed product performance criterion.•Please comment on the scientific soundness of the product performance criterion recommended in the draft guidance document to support the registration of pesticide products with a prion claim.12:00 P.M. Lunch1:00 P.M. Charge to Panel – Question 44. Efficacy Guidance Labeling Claim Issue: Whether the labeling claim described in the draft guidance document is scientifically appropriate based on the recommended test systems and product performance standard.The draft efficacy guidance document recommends a carefully worded labeling claim statement: “Has been demonstrated to reduce infectivity of prions (TSE agents) based on testing using (insert type of organism in which the prions were raised) (insert prion type).” EPA believes that claims that may normally be applied to microorganisms (e.g., “destroy,” “mitigate,” “eliminate,” “control”) may be misleading when applied to prions. Because currently available test methods can only measure a reduction in infectivity, and the total elimination or destruction of prions cannot be•5. Efficacy Guidance Hierarchy Issue: Whether different prion types exhibit variation in the degree of resistance to inactivation by pesticide chemicals and whether a hierarchy of resistance by prion type can be reliably determined at this time.Comparisons of different types of prions in a common animal infectivity assay indicate there may be significant differences with regard to their ability to resist inactivation by pesticide chemicals. For example, Peretz et al. (2006) compared the resistance of hamster scrapie and human CJD prions in transgenic mice expressing either hamster PrP or a chimeric mouse-human PrP transgene and found that human sCJD prion tested was 100,000 fold more difficult to inactivate than hamster Sc237 prion. Preliminary additional studies indicate that the cow BSE prion may be even more resistant to inactivation than the human CJD prion (Giles et al. 2006; 2008 in press).measured, EPA believes that “reduce infectivity” is the only appropriate claim.Please comment on the scientific appropriateness of the term “reduce infectivity” in a label claim to reflect the action of a pesticide on prions.3:00 P.M. Break3:15 P.M. Charge to Panel – Question 5•Please comment on whether a hierarchy of resistance among prion types can be reliably demonstrated for different pesticide chemicals based on the available data.5:00 P.M. AdjournmentPlease be advised that agenda times are approximate; when the discussion for one topic is completed, discussions for the next topic will begin. For further information, please contact the





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FIFRA Scientific Advisory Panel; Notice of Public Meeting PDF Version (3 pp, 80K, About PDF)

[Federal Register: December 17, 2008 (Volume 73, Number 243)] [Notices] [Page 76639-76641] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr17de08-76]

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ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2008-0859; FRL-8392-9]

FIFRA Scientific Advisory Panel; Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA). ACTION: Notice.

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SUMMARY: There will be a 2-day meeting of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to consider and review Scientific Issues Associated with Designating a Prion as a ``Pest'' under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and Related Efficacy Test Methods.





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Associated with Designating a Prion as a "Pest" under the Federal insecticide,. Fungicide, and Rodenticide Act (FlFRA), and Related Efficacy Test Methods. These ... whether Prions Are a Pest' under the Federal insecticide, Fungicide, and Rodenticide Act (fifra)." 2. Efficacy Guidance Test Method issue: Whether the ...





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Friday, August 29, 2008 CREEKSTONE VS USDA COURT OF APPEALS, BUSH SAYS, NO WAY, NO HOW




http://madcowtesting.blogspot.com/2008/08/creekstone-vs-usda-court-of-appeals.html




Subject: Importation of Whole Cuts of Boneless Beef from Japan [Docket No. 05-004-1] RIN 0579-AB93 TSS SUBMISSION

Date: August 24, 2005 at 2:47 pm PST

August 24, 2005

Importation of Whole Cuts of Boneless Beef from Japan [Docket No. 05-004-1] RIN 0579-AB93 TSS SUBMISSION

Greetings APHIS ET AL,

My name is Terry S. Singeltary Sr.

I would kindly like to comment on [Docket No. 05-004-1] RIN 0579-AB93 ;

PROPOSED RULES

Exportation and importation of animals and animal products:

Whole cuts of boneless beef from-

Japan,

48494-48500 [05-16422]




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Docket No. 03-080-1 -- USDA ISSUES PROPOSED RULE TO ALLOW LIVE ANIMAL IMPORTS FROM CANADA




https://web01.aphis.usda.gov/BSEcom.nsf/0/b78ba677e2b0c12185256dd300649f9d?OpenDocument&AutoFramed




PLEASE SEE FULL TEXT HERE ;

Docket No. 03-080-1 -- USDA ISSUES PROPOSED RULE TO ALLOW LIVE ANIMAL IMPORTS FROM CANADA




http://madcowfeed.blogspot.com/2008/07/docket-no-03-080-1-usda-issues-proposed.html




Docket APHIS-2006-0026 Docket Title Bovine Spongiform Encephalopathy; Animal Identification and Importation of Commodities Docket Type Rulemaking Document APHIS-2006-0026-0001 Document Title Bovine Spongiform Encephalopathy; Minimal-Risk Regions, Identification of Ruminants and Processing and Importation of Commodities Public Submission APHIS-2006-0026-0012 Public Submission Title Comment from Terry S Singletary




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Docket APHIS-2006-0041 Docket Title Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Importation of Live Bovines and Products Derived from Bovines Commodities Docket Type Rulemaking Document APHIS-2006-0041-0001 Document Title Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Importation of Live Bovines and Products Derived >From Bovines Public Submission APHIS-2006-0041-0028 Public Submission Title Comment from Terry S Singletary

Comment 2006-2007 USA AND OIE POISONING GLOBE WITH BSE MRR POLICY

THE USA is in a most unique situation, one of unknown circumstances with human and animal TSE. THE USA has the most documented TSE in different species to date, with substrains growing in those species (BSE/BASE in cattle and CWD in deer and elk, there is evidence here with different strains), and we know that sheep scrapie has over 20 strains of the typical scrapie with atypical scrapie documented and also BSE is very likely to have passed to sheep. all of which have been rendered and fed back to animals for human and animal consumption, a frightening scenario. WE do not know the outcome, and to play with human life around the globe with the very likely TSE tainted products from the USA, in my opinion is like playing Russian roulette, of long duration, with potential long and enduring consequences, of which once done, cannot be undone. These are the facts as I have come to know through daily and extensive research of TSE over 9 years, since 12/14/97. I do not pretend to have all the answers, but i do know to continue to believe in the ukbsenvcjd only theory of transmission to humans of only this one strain from only this one TSE from only this one part of the globe, will only lead to further failures, and needless exposure to humans from all strains of TSE, and possibly many more needless deaths from TSE via a multitude of proven routes and sources via many studies with primates and rodents and other species.

MY personal belief, since you ask, is that not only the Canadian border, but the USA border, and the Mexican border should be sealed up tighter than a drum for exporting there TSE tainted products, until a validated, 100% sensitive test is available, and all animals for human and animal consumption are tested. all we are doing is the exact same thing the UK did with there mad cow poisoning when they exported it all over the globe, all the while knowing what they were doing. this BSE MRR policy is nothing more than a legal tool to do just exactly what the UK did, thanks to the OIE and GW, it's legal now. and they executed Saddam for poisoning ???

go figure. ...




http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=09000064801f8151




Docket APHIS-2006-0041 Docket Title Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Importation of Live Bovines and Products Derived from Bovines Commodities Docket Type Rulemaking Document APHIS-2006-0041-0001 Document Title Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Importation of Live Bovines and Products Derived >From Bovines Public Submission APHIS-2006-0041-0006 Public Submission Title Comment from Terry S Singletary Sr Views Add Comments How To Comment

snip...

MY personal belief, since you ask, is that not only the Canadian border, but the USA border, and the Mexican border should be sealed up tighter than a drum for exporting there TSE tainted products, until a validated, 100% sensitive test is available, and all animals for human and animal consumption are tested. all we are doing is the exact same thing the UK did with there mad cow poisoning when they exported it all over the globe, all the while knowing what they were doing. this BSE MRR policy is nothing more than a legal tool to do just exactly what the UK did, thanks to the OIE and GW, it's legal now. and they executed Saddam for poisoning ???

go figure....

Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518




http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&d=APHIS-2006-0041-0006




From: Terry S. Singeltary Sr.

To: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000202/!x-usc:mailto:FREAS@CBER.FDA.GOV

Cc: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000202/!x-usc:mailto:william.freas@fda.hhs.gov ; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000202/!x-usc:mailto:rosanna.harvey@fda.hhs.gov

Sent: Friday, December 01, 2006 2:59 PM

Subject: Re: TSE advisory committee for the meeting December 15, 2006 [TSS SUBMISSION

snip...

ONE FINAL COMMENT PLEASE, (i know this is long Dr. Freas but please bear with me)

THE USA is in a most unique situation, one of unknown circumstances with human and animal TSE. THE USA has the most documented TSE in different species to date, with substrains growing in those species (BSE/BASE in cattle and CWD in deer and elk, there is evidence here with different strains), and we know that sheep scrapie has over 20 strains of the typical scrapie with atypical scrapie documented and also BSE is very likely to have passed to sheep. all of which have been rendered and fed back to animals for human and animal consumption, a frightening scenario. WE do not know the outcome, and to play with human life around the globe with the very likely TSE tainted blood from the USA, in my opinion is like playing Russian roulette, of long duration, with potential long and enduring consequences, of which once done, cannot be undone.

These are the facts as i have come to know through daily and extensive research of TSE over 9 years, since 12/14/97. I do not pretend to have all the answers, but i do know to continue to believe in the ukbsenvcjd only theory of transmission to humans of only this one strain from only this one TSE from only this one part of the globe, will only lead to further failures, and needless exposure to humans from all strains of TSE, and possibly many more needless deaths from TSE via a multitude of proven routes and sources via many studies with primates and rodents and other species. ...

Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518

snip... 48 pages...




http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064801f3413&disposition=attachment&contentType=msw8




Docket Management Docket: 02N-0273 - Substances Prohibited From Use in

Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed

Comment Number: EC -10

Accepted - Volume 2




http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be07.html




PART 2




http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be09.html




Thursday, March 19, 2009

MILLIONS AND MILLIONS OF POUNDS OF MAD COW FEED IN COMMERCE USA WITH ONGOING 12 YEARS OF DENIAL NOW, WHY IN THE WORLD DO WE TO TALK ABOUT THIS ANYMORE $$$




http://madcowfeed.blogspot.com/2009/03/millions-and-millions-of-pounds-of-mad.html





Saturday, January 24, 2009

Bovine Spongiform Encephalopathy h-BSE ATYPICAL USA 2008 Annual Report Research Project: Study of Atypical Bse

Location: Virus and Prion Diseases of Livestock

2008 Annual Report




http://bse-atypical.blogspot.com/2009/01/bovine-spongiform-encephalopathy-h-bse.html




Thursday, December 04, 2008 2:37 PM

"we have found that H-BSE can infect humans."

personal communication with Professor Kong. ...TSS

see full text ;




http://bse-atypical.blogspot.com/2009/02/atypical-bse-north-america-update.html






----- Original Message -----

From: "Terry S. Singeltary Sr." mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000202/!x-usc:mailto:flounder9@verizon.net To: "Bovine Spongiform Encephalopathy" mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000202/!x-usc:mailto:BSE-L@aegee.org Cc: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000202/!x-usc:mailto:heggem.daniel@epa.gov; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000202/!x-usc:mailto:sibert.christopher@epa.gov; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000202/!x-usc:mailto:denne.jane@epa.gov; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000202/!x-usc:mailto:hazen.susan@epa.gov; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000202/!x-usc:mailto:mcrosby@ucsusa.org; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000202/!x-usc:mailto:erobinson@ucsusa.org; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000202/!x-usc:mailto:enegin@ucsusa.org; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000202/!x-usc:mailto:cjdvoice@yahoogroups.com; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000202/!x-usc:mailto:madcow@lists.iatp.org

Sent: Monday, April 28, 2008 9:48 PM

Subject: Interference at the EPA Science and Politics at the U.S. Environmental Protection Agency




http://madcowfeed.blogspot.com/2008/08/texas-firm-recalls-cattle-heads-that.html






TSS